Application of ROTEM Technology in Aortic Surgery

Aortic Surgery Clinical Trial

Official title:

Application of ROTEM Technology in Aortic Surgery Under Cardiopulmonary Bypass and Circulatory Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05171023
• Other study ID #: 20210916-11
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: August 25, 2023

Study information

• Verified date: August 2023
• Source: Petrovsky National Research Centre of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and standard coagulogram in the detection of disorder and correction of the hemostasis system in the perioperative period in patients who underwent surgical intervention on the aorta under cardiopulmonary bypass and or circulatory arrest.

Description:

The patient is monitored in the intensive care unit according to the following scheme: ROTEM (NATEM, INTEM, EXTEM, FIBTEM; with high clotting time (CT) values in INTEM - HEPTEM is done) and a coagulogram (activated coagulation time (ACT), activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen, antithrombin III, platelet aggregation) are done on admission and after 6 hours - with a smooth course of the perioperative period. If it is necessary or the development of disorders in the form of bleeding or thrombosis that require correction, ROTEM and a coagulogram are done, treatment is carried out, and after elimination of the causes, ROTEM and a coagulogram are examined in dynamics to assess the effectiveness of the therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 25, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 80 years.
• Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest (operations on the ascending aorta, aortic arch and thoracoabdominal aorta).

Exclusion Criteria:

• Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.

Related Conditions & MeSH terms

• Aortic Surgery
• Coagulation Management

Intervention

Device:
• ROTEM and standard coagulation tests
ROTEM and standard coagulation tests assessment

Locations

Country	Name	City	State
Russian Federation	Petrovsky National Research Centre of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The coagulation index	?hanges of the coagulation index	an average of during the first day after surgery
Primary	Activated coagulation time	?hanges of the activated coagulation time	an average of during the first day after surgery
Secondary	Percentage of repeated operations	Percentage of repeated operations	an average of 24 hours after surgery
Secondary	Percentage of multiple organ failure	Percentage of multiple organ failure	an average of 24 hours after surgery
Secondary	Percentage of serious infectious complication	Percentage of serious infectious complication	an average of 24 hours after surgery